Introduction
Standards may simply be defined as a set of rules for ensuring quality; they define how most
products, processes, and people interact with each other and their environments. They enhance
competitiveness by offering proof that products and services adhere to requirements of
governments or the marketplace. Standards also spur and disseminate innovation, solve
coordination failures, and facilitate the development of profitable networks.
Quality and standards are inherently linked. Quality is the degree to which the innate
characteristics of a product, process, or person fulfill stated and unstated customer
requirements and expectations; comply with stated norms, regulations, and laws; or both.
Standards are often used to codify technological requirements expected by customers or
governments, making them an essential element in the effort to upgrade quality in a country.
The National Quality Infrastructure (NQI) is the institutional framework that establishes and
implements the practice of standardization, including conformity assessment services,
metrology, and accreditation. This brief outlines the central components of the NQI, discusses
measures to develop an effective quality system, and addresses challenges to implementation.
Standards that are not well documented, difficult to find, or imprecisely defined can hinder trade.
Moreover, using country-specific standards makes it more difficult to realize global economies of
scale. The proliferation of standards may impose additional costs on firms. Among firms
surveyed in the Latin America region, those facing technical regulations have additional
compliance costs for each export market, which can increase their investment costs up to 10
percent (World Bank 2007). Governments can play an important role in facilitating trade by
harmonizing national standards with international ones. In addition, governments can facilitate
diffusion of international standards and the standards of major trade partners to leading export
industries.
Standards are used to codify the technical characteristics and market preferences for products
and processes, facilitating knowledge absorption and technological change. Standards have
proven effective in promoting the adoption of desirable process and product characteristics
(reliability, durability, and so on) and providing roadmaps to improve quality. For example, the
International Standards Organization ISO 9001 standard provides an organization with a model
to follow for the design, implementation, and assessment of quality management systems.
Standards are also credited with fostering the diffusion of technological best practices. When
knowledge is exchanged in private transactions, it does not spill over to third parties. However,
because information embodied in standards is nonproprietary, it creates a pool of technical
information that can be transferred across companies and countries, freely accessed by
entrepreneurs, scientists, and engineers and used to generate new ideas and technologies.
Conformity Assessment
Conformity assessment comprises testing, inspection, and certification of products or services.
Testing is the determination of a product’s characteristics against the requirements of the
standard. Inspection encompasses the examination of a product design, end product, or
process, and the determination of its conformity with requirements. Certification is the formal
substantiation by a certification body after an evaluation, testing, inspection, or assessment, that
a product, service, organization, or individual meets the requirements of a standard.
In many countries, conformity assessment services are increasingly being provided by the
private sector rather than governments, while governments retain responsibility for maintaining
the fundamentals—standards, metrology, and accreditation. Typically, the larger and more
industrialized the economy, the more the private sector is involved. FDI has been a driving force
for certification to international standards in many developing countries following the
liberalization of the market and international harmonization of standards. This situation has
given rise to a number of multinational conformity assessment bodies, most operating as private
for-profit companies.
Source:
World
Bank
2007.
Metrology
Metrology is the science of measurement. It can be subdivided as follows:
Accreditation
Accreditation is the procedure by which an authoritative body (the accreditation body) formally
recognizes that an organization is competent to conduct specified conformity assessment
services (that is, testing, inspection, or certification). The accreditation body evaluates the
personnel and supporting management system of the candidates for accreditation and can
request practical tests for laboratories when relevant.
Most countries have a single national accreditation body responsible for all areas of
accreditation in order to benefit from the economies of scale and economies of learning in
accreditation, as well as to provide a single point for international agreement. A single
accreditation body also avoids confusion in the market, which could arise if multiple agencies
claim to be at the top of the NQI chain. When a country does not have an accreditation body,
certification bodies can seek accreditation abroad, though this is often a suboptimal solution.
Such overly restrictive and mandatory technical regulations stifle trade. Countries should
minimize such restrictive measures to only what is necessary for safety and health. Restrictive
measures also stifle innovation and make it difficult for firms to develop or import new products
that do not meet existing and often outdated standards. By decreasing variety, excessive
technical regulations also reduce diversity in the pool of products that can be used as the basis
for future innovation.
Many
countries have transitioned from mandatory certification to market surveillance, a more
efficient and less burdensome means of ensuring that products and processes adhere to
technical regulations. Market surveillance and the use of self-certification have several
advantages over mandatory certification. Under a market surveillance system, producers are
responsible for using internal processes to ensure that their products are in compliance with the
necessary regulations; in some cases, they may be required to apply a mark of conformity to the
product. A gradual transition from mandatory certification to market surveillance would
significantly reduce the financial and technical burden imposed on producers.
Conflicts of interest
In some countries, the NQI system is centrally controlled by the state and the same institution is
responsible for the conducting standard development, certification, and accreditation activities,
posing a significant conflict of interest. In Ukraine, for example, the State committee for
Technical Regulations and Consumer Protection (Derzhstadart) is responsible for the
development and approval of standards, product certification, inspection of producers, market
surveillance, and consumer protection. Because the entire process is completely controlled by
one organization, the overlap of commercial and regulatory functions and the discretionary
powers of the organization to control the certification market creates considerable conflicts of
interest. Similarly in Bolivia a single entity is responsible for providing industrial calibration
services to the market and accreditation services for market players who compete with its own
calibration services.
Limited Financing
Particularly in developing countries, funding constraints, combined with a failure by the
government to appreciate the importance of the NQI, can limit the resources available for
reform. NQI upgrading requires a significant time and financial investment (Table 1). The
funding needed for the development of a standardization system alone, including expertise
transfer, development of technical committees, and purchase of information technology, may
reach US$2 million over five years. Most of the operating costs of the standards body must also
be covered by the government. Although membership fees and sales of standards generate
income, it is unlikely to be sufficient to cover operating costs in most small economies and in
economies where demand for voluntary standards remains low.
At the firm level, limitations in time and financing impede implementation of an NQI system.
Implementation time depends on many factors, including the level of complexity of the company,
level of quality in production, the skill level of personnel, and the degree of management
commitment to upholding standards. It may be necessary to hire new personnel and restructure
parts of the company. The financial cost of implementing quality management systems can be a
barrier to certification, especially for small and medium enterprises.
In more technical areas like metrology, specialized personnel are needed to guarantee the
reliability of an NQI system. To ensure accurate measurement, well-equipped laboratories, as
well as scientific personnel with specialized training and research experience, are needed.
Similarly, the objectivity of the accreditation and conformity assessment processes largely
depends on the quality of the technical staff.
Once institutions have been reformed or upgraded in the context of harmonization with
international norms for NQI—including the adoption of relevant management processes—
capacity building and technology upgrading can be targeted to individual aspects of NQI to
achieve quick wins, provide demonstration effects, and avoid repeating mistakes. The end goal
should be to have an internationally harmonized NQI that responds to the needs of society
NQI Strategy
NQI systems are at different levels of development across countries and regions. An initial step
in upgrading NQI is to conduct an assessment and develop a strategy for upgrading,
harmonization, and reform, as appropriate. In many countries, the level of NQI infrastructure
development feasible in initial stages may be constrained by cost and capacity, necessitating
choices about which minimum infrastructure and services are necessary. Governments have
typically taken a lead role in this process.
The development of an NQI strategy should involve stakeholders. One successful method is to
develop a national quality council that identifies needs and articulates a response strategy. The
council provides a forum for gathering and disseminating information and discussing and solving
problems. Its tasks should be defined by the stakeholders, but should include coordinating and
implementing the national strategy for NQI. Strategies for individual NQI institutions can then be
derived from the national strategy.
Once a clear strategy has been developed, a legal framework must be developed to ensure
proper functioning of the NQI. National legislation must be drafted or updated to reflect the
agreed upon structure, governance, and functions of the NQI. It must also reflect the World
Trade Organization’s Technical Barriers to Trade principles, the guidelines of the main
international NQI bodies, and the direction of a national NQI strategy.
To achieve well-governed institutions free from conflicts of interest, countries may need to
reform and restructure their NQI and create independent, transparent institutions that are
responsive to all stakeholders in the system. Minimum standards include the following:
A limited set of technical regulations can be developed to protect consumers, health, safety, and
the environment. According to many good practices across the world, technical regulations are
developed by government, often by designated regulatory agencies under ministries, with no
involvement of the national standardization body. Reviews of technical regulations should
ensure that they do not impose technical barriers to trade and unnecessary constraints to
businesses.
Conformity Assessment
Two ways in which governments can enforce technical regulations are (1) requiring a premarket
approval of products through mandatory certification and (2) conducting market surveillance,
allowing companies to certify that certain standards have been met and then verifying this
through spot checks and consumer complains. Developed countries have tended to move
toward market surveillance.
Within market surveillance, a government monitoring agency has the duty to ensure that only
complying products are placed on the market by testing products and applying appropriate
sanctions to the supplier. Under these methods, governments relinquish some of their
involvement in the certification process by transferring the responsibility for conformity with
technical regulations to the producer. While this practice can be beneficial in minimizing
government activities required for conformity assessment, it is not suitable for every product.
Products deemed as particularly dangerous still require mandatory certification.
Ensuring that conformity assessment systems are harmonized with international standards and
guidelines is also important for global integration. Accreditation is the last level of quality control
in conformity assessment, since it can provide credibility to certification, testing, inspection, and
calibration bodies so that their services are recognized and respected domestically and abroad.
Metrology
A first step in modernizing a metrological framework is to conduct a needs and gap assessment
of the measurement standards currently in place, what they cover, whether they meet
requirements and at what level of accuracy. A new approach for the selection of equipment and
reference standards needs to be applied in market economies. Metrological needs should be
determined by conducting a thorough and realistic demand survey.
Countries typically have a single national scientific metrology institution responsible for
disseminating measurements in the economy in all areas of metrology. A single institution is
economically necessary because (1) scientific metrology is very expensive, so having more than
one national reference standard for the same measurement would not be viable; (2) it requires
technical skills that are particularly scarce in developing countries; (3) it requires adopting
international process standards that are difficult and lengthy to implement; and (4) it requires
participating in international inter-comparisons4 to ensure that the national metrology institution’s
measurements are recognized across borders and that those measurements in industry that are
traceable to the NMI’s measurements, through calibration, are also recognized by trade
partners.
Calibration laboratories help firms ensure that their equipment allows them to manufacture
products in accordance with buyer requirements. To play a credible role in the conformity
assessment system, testing and calibration laboratories and inspection bodies must display
many of the same characteristics as certification bodies, notably, impartiality, objectivity, and
confidentiality. Objectivity relies heavily on the procedures guiding the evaluation process, the
equipment used, and the skills and qualifications of staff. Equipment and measurement
Accreditation
To ensure an impartial, objective, and technically credible accreditation system, it must be
completely separate from regulatory, conformity assessment, and metrology functions. All
scopes of accreditation should fall under the responsibility of a single body. Conformity
assessment bodies involved in regulatory and voluntary markets should be subject to the same
accreditation systems. Internal laboratories and commercial laboratories should also be subject
to the same voluntary accreditation system.
Most solid accreditation systems are built through international and regional cooperation, most
often in the form of compliance with guidelines and membership in international or regional
accreditation organizations. Where there is no regional accreditation body, small economies can
join forces to develop and share accreditation capabilities, thereby reducing costs, although this
is rarely done.
Conclusion
The National Quality Infrastructure is an important tool that can be utilized to improve
competitiveness and facilitate global trade. Countries can become more competitive by
abolishing overly-restrictive mandatory standards and harmonizing standards with regional and
international trade partners. This should be complemented by the development of quality
institutions which embody the principles of transparency, openness and good governance.
Governments have a central role to play in the development and upgrading of National Quality
Infrastructure institutions, to facilitate international harmonization and recognition.
References
Morrison, W. M. 2007. “Health and Safety Concerns over U.S. Imports of Chinese Products: An Overview.”
Congressional Research Service Report for Congress, U.S. Congress, Washington, DC.
http://assets.opencrs.com/rpts/RS22713_20070828.pdf.
World Bank. 2007. Quality Systems and Standards for a Competitive Edge., World Bank, Washington, DC
1
The most famous example is the ISO 9001 quality management systems standard.
2
For the past decade, the trend throughout the world has unambiguously shifted toward
voluntary standards, largely driven by WTO and EU membership requirements.
3
For example, the legacy of the Gosstandart system is strong in a number of Commonwealth of
Independent States (CIS) countries for a variety of reasons. Most importantly, trading in CIS
countries is still dominated by intraregional trade, particularly with the Russian Federation,
which continues to use a derivative of the Gosstandart system. For a country that trades mostly
with the CIS, reforming away from a Gosstandard system toward international best practice
models would mean losing markets without a guarantee of finding new ones.
4
This includes the International Committee of Weights and Measures (CIPM) MRA.
5
Such standards include International Organization for Standardization (ISO) and International
Electrotechnical Commission (IEC) standards: ISO/IEC guides 17021, 17024, and EN 45011 for
certification bodies; ISO standard 17025 for calibration and testing laboratories; ISO 15189 for
clinical testing laboratories; ISO 15195 for clinical reference/calibration laboratories; and
ISO/IEC standard 17020 for inspection bodies.